Kornimate/medical-research-clean huggingface dataset:
a study of multiple doses of vesnarinone in advanced hiv disease

Conditions: HIV Infections

Summary: to evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced hiv disease.

fourteen patients per dose level receive vesnarinone at 1 of 4 doses for 12 weeks. at least seven patients at a given dose level must have completed 4 weeks of treatment before dose is escalated in subsequent patients.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * chemoprophylaxis for pneumocystis carinii, candida, mycobacteria, and other opportunistic infections. * acyclovir for up to 14 days for acute herpes outbreaks. patients must have: * documented hiv infection. * cd4 count 50 - 300 cells/mm3. * no active opportunistic infections. * no fever, diarrhea, or herpes zoster. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * clinically significant current cardiac disease, including patients who exhibit long qtc syndrome on ekg screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline. * active malignancy (other than cutaneous kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix). concurrent medication: excluded: * antiretroviral agents, including ddi, ddc, azt, and d4t. * immunosuppressive agents. * investigational hiv drugs/therapies including vaccines. * interferon or other immunomodulating agents. * corticosteroids (other than topical). * hematopoietins. * megestrol acetate. * agents known to cause neutropenia. * trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. * cytotoxic chemotherapy. concurrent treatment: excluded: * radiation therapy. patients with the following prior conditions are excluded: * prior history of cardiac disease. * history of agranulocytosis or severe (grade 3 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function. prior medication: excluded: * azt, ddi, ddc, d4t, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry. * prior cytotoxic chemotherapy. * acyclovir for herpes prophylaxis within 48 hours prior to study entry. prior treatment: excluded within 30 days prior to study entry: * erythropoietin, transfusion, or blood product use. * radiation therapy (including electron beam irradiation). active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).

Keywords: acquired immunodeficiency syndrome antiviral agents vesnarinone
clostridium difficile vaccine safety, tolerability, and immunogenicity study in japanese adults

Conditions: Clostridium Difficile Associated Disease

Summary: the first-in-japanese study b5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of c difficile vaccine when administered as one of two 3-dose regimens to healthy japanese adults aged 65 to 85 years.


Eligibility criteria:
inclusion criteria: 1. healthy male and female adults 2. aged 65 to 85 years exclusion criteria: 1. proven or suspected prior episode of clostridium difficile associated diarrhea 2. unstable chronic medical condition 3. disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine 4. serious chronic medical disorders 5. bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection 6. any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components 7. subjects with congenital or acquired immunodeficiency disorders 8. subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications 9. active or treated leukemia or lymphoma or bone marrow disorder 10. residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living 11. abnormality in screening hematology and/or blood chemistry laboratory values
level of immunity, neutralization of the covid-19 virus and reinfections in residents of 2 migrant workers' residences

Conditions: SARS-COV-2

Summary: a previous seroprevalence survey showed very high seroprevalence levels among residents of the two among the residents of the two migrant workers' hostels surveyed, indicating a high level of circulation of the virus sars-cov-2 during the 1st wave of covid-19. the constitution of a cohort after the event would be an opportunity to obtain opportunity to obtain answers to crucial questions: duration of immunity, potential reinfections potential reinfections, potential re-clustering. going back to check the serological status seems feasible, especiallyespecially in the foyers de travailleurs migrants (high probability of finding the participants). there is an obvious scientific interest around the duration of immunity and reinfections in a population highly exposed during the first wave. several articles document the decline of igg antibodies in the months following an infection, but very few infection, but very few evaluate the protective character in the medium term (\>=6 months), especially in asymptomatic individuals. we are also concerned about the circulation of we are also concerned about the circulation of new variants and the immunity acquired after infection in residents. to date, no study on the duration of immunity has been conducted in migrant worker's residences.


Eligibility criteria:
inclusion criteria: * all individuals who consented to participate in the 1st study and who consent to participate in this study * all individuals 18 years of age or older not residing in the 2 mwrs in july 2020 and permanently living in the mwr since september 2020 who consent to participate in this study exclusion criteria: * unwillingness to provide informed consent * unwillingness to provide blood * contraindication to venepuncture

Keywords: covid-19 migrant workers' residences immunity protection
pragmatic investigation of optimal oxygen targets trial

Conditions: Respiratory Failure

Summary: mechanical ventilation of icu patients universally involves titration of the fraction of inspired oxygen (fio2) to maintain arterial oxygen saturation (spo2). despite decades of icu practice, however, the optimal spo2 target remains unknown. current guidelines offer divergent recommendations as to the optimal spo2 target. therefore, we propose a 2,250-patient cluster-randomized cluster-crossover trial comparing a lower spo2 target (90%; range 88-92%), an intermediate spo2 target (94%; range 92-96%), and a higher spo2 target (98%; range 96-100%) with regard to the outcome of days alive and free of invasive mechanical ventilation.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. receiving mechanical ventilation through an endotracheal tube or tracheostomy 3. admitted to the study icu or admission to the study icu from the emergency department is planned exclusion criteria: 1. known pregnancy or beta hcg level greater than the laboratory upper limit of normal in a patient capable of becoming pregnant 2. known to be a prisoner
prosabi: prospective multi-centre study of prognostic factors in mcrpc patients treated with abiraterone acetate.

Conditions: Advanced Prostate Cancer; Abiraterone ACetate

Summary: prosabi is a prospective multicentre observational study in metastatic castration-resistant prostate cancer (mcrpc), designed to explore prognostic biomarkers in patients undergoing treatment with abiraterone

this study is a prospective biomarker study of patients with mcrpc undergoing treatment with abiraterone as standard of care treatment. the participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility criteria:
inclusion criteria: 1. male age ≥ 18 years 2. histologically confirmed adenocarcinome of the prostate 3. ecog performance status ≤ 2 4. castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/ml (\< 2.0 nm). 5. men diagnosed with at least one metastatic lesion on ct or bone scan. 6. documented biochemical and/or radiographic progression to previous treatment according to pcwg2 criteria. 7. patients who are candidates for standard of care treatment with abiraterone acetate: 1000 mg every 24 hours plus prednisone 5 mg every 12 hours. 8. availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy. 9. acceptable hematological, hepatic and renal functions.9. acceptable haematological, hepatic and renal functions. exclusion criteria: 1. previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas. 2. any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data

Keywords: metastatic castration resistant prostate cancer abiraterone acetate biomarkers
in vitro maturation of immature oocytes

Conditions: Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome

Summary: the aim of this study is to aspirate immature oocytes from antral follicles and mature the oocytes in vitro. these mature oocytes will serve for fertilization and the creation of embryos which will be replace in the uterus as performed during normal ivf.we will record the efficacy and safety of this procedure.


Eligibility criteria:
inclusion criteria: * women with pcos * women with previous hyperstimulation or with risk of developing hyperstimulation during ivf treatment * women diagnosed with cancer who are interested in fertility preservation * women with repeated ivf failure exclusion criteria: * severe cases of endometriosis * large myomas * hydrosalpinxs technical problem with previous oocytes pick-up

Keywords: pcos fertility preservation repeated ivf failure s/p hyperstimulation
procedural learning in participants with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: skill acquisition refers to the process of improvement of performance following practice experience. this process is the basis for generation of a long-lasting memory. individuals with attention deficit hyperactivity disorder (adhd) have been shown to be impaired on some performance aspects of previously learned skills, an impairment that is often ameliorated, at least temporarily, by psychostimulant medication (the standard therapy in adhd). the proposed study aims to define the course of learning and of generation of long-term memory consolidation in individuals with adhd, and to essay the effectiveness of psychostimulant medication on both the learning and retention of the skills.

skill acquisition and the evolution of long term procedural memory in participants with adhd: the effect of methylphenidate

Eligibility criteria:
inclusion criteria: * full scale iq score of 85 or above

Keywords: skill acquisition and the evolution of long term procedural memory in participants with adhd: the effect of methylphenidate
an open-label, non-controlled study of khk4827 in subjects with psoriasis

Conditions: Psoriasis

Summary: this study is an open-label, non-controlled study to evaluate the efficacy and safety of khk4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. pharmacokinetics of khk4827 will also be assessed.


Eligibility criteria:
inclusion criteria: * subject has signed voluntarily the written informed consent form to participate in this study. * subject has been diagnosed as pustular psoriasis or psoriatic erythroderma. * subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator. exclusion criteria: * subject with psoriatic erythroderma has involved body surface area (bsa) of lesion \< 80% at baseline. * subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis. * evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of khk4827 on psoriasis. * subject has any active common terminology criteria for adverse events (ctcae) grade 2 or higher infection * subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol. * subject has used ultra violet b (uvb) therapy within 14 days of the first dose or ultra violet a (uva) (with or without psoralen) within 28 days of the first dose. * subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively. * subject has stopped ustekinumab or other anti-interleukin (il)-23 biologics therapy due to lack of efficacy * subject has used live vaccine within 3 months of the first dose * subject has previously used an anti-il-17 biologic therapy
feasibility trial to evaluate the ability of the sumo tissue access and resection system

Conditions: Colon Disease; Gastric Disease

Summary: this feasibility trial will evaluate the ability of the sumo tissue access and resection system (apollo endosurgery, austin, texas). the sumo system utilizes balloons to create a submucosal pocket and electrosurgical cutting device to resect the mucosa. the sumo elevates the tissue from the underlying muscularis using a balloon to distend the submucosa, similar to what is currently performed with injectable saline in a standard emr. after dissection of the lesion, a separate cutting device will be utilized to resect the tissue by cutting around the border of the targeted tissue. if needed, a standard loop snare will be used to complete the mucosal resection.

the subject will already be scheduled for segmental colectomy or gastrectomy. the colectomy or gastrectomy specimen will be prepared on a side table for an ex vivo endoscopic procedure. the ends of the stomach or colon, if not already stapled closed will be ligated to allow for insufflation. the endoscope will be placed into the excised organ and the sumo system devices will be deployed away from any areas of excised pathologic tissue, so as not to disrupt the pathologist's evaluation of the excised tissue. the specimen will then be opened and grossly examined for the actual completeness of the submucosal pocket and resection. mucosal and muscular wall disruptions will be assessed. again, no interference in the underlying pathology will be performed. if sufficient specimen is present, the sumo procedure may be repeated on the same specimen. following the performance of the emr by the sumo balloon system on the ex vivo colon specimen, both the resected piece of tissue and the site of resection will be evaluated pathologically by h and e staining. specifically, the depth of resection in the ex vivo colon specimen will be determined. in addition, the level of dissection on the removed piece of mucosa will also be identified. during this procedure still images or a video recording maybe captured, however all images will be taken of the removed specimen. there will not be any patient identifiers on any of the images or dvd's taken during the procedure. no clinical follow up is required, as the treated area will have already been resected and there is no risk to the patient.

Eligibility criteria:
inclusion criteria: * male or female over 18 years of age * established indication for open or laparoscopic or colon resection or gastrectomy * subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form exclusion criteria: * subjects that are minors or prisoners * subjects who would have difficulty comprehending or complying with the requirements of the study * subjects who fail to give informed consent

Keywords: resection open laparoscopic benign malignant disease colon gastric
trans-pulmonary pressure in ards

Conditions: Acute Respiratory Distress Syndrome

Summary: adequate peep selection in ards is still a matter of research. the main objectives of using peep in ards are improvement in oxygenation, lung recruitment at the end of expiration, prevention of opening and closing of terminal respiratory units at minimal hemodynamic compromise. the challenge is to carry out these objectives in a patient-centered approach based on individual characteristic of lung pathophysiology. recently, it has been proposed to set peep from the trans-pulmonary end-expiratory pressure. trans-pulmonary pressure (ptp) is obtained from the difference between airway pressure and measured esophageal pressure (pes). measured pes values have been found positive in the supine position in ards patients, leading to negative values of ptp. the strategy proposed by talmor and coworkers is to adjust peep up to get ptp between 0 and 10 cm h2o. whether this strategy improves survival is under investigation. prone position ventilation significantly improves survival in severe ards as demonstrated by meta-analyses and a recent multicenter randomized controlled trial. the purpose of present project is to investigate ptp at end-expiration in the prone position in severe ards. the project is centered on the question about what are the values of measured pes in prone position. the hypothesis is that they are lower than in the supine position due to the relief of the weight of heart, mediastinum and lung and also to recruitment of dorsal lung regions. to investigate this hypothesis, measured pes, ptp, end-expiratory lung volume, overall lung recruitment (pressure-volume curve), and regional recruitment by using electrical impedance tomography. will be assessed in supine then in the prone position across two different strategies of peep selection, peep/fio2 table and talmor proposal.


Eligibility criteria:
inclusion criteria: * ards * intubated * indication of proning * no contra-indication of proning exclusion criteria: * contra-indication to proning * contra-indication to esophageal balloon * proning before * end of life decision * legal protection * pregnancy * ecmo

Keywords: ards prone position peep mechanical ventilation
outcome comparison between pfna and intertan

Conditions: Intertrochanteric Fracture

Summary: the purpose of this study is to determine whether this two intramedullary fixations are effectively in the treatment of intertrochanteric fracture.

with the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. the best recommend treatment is surgical treatment of intramedullary fixation. however, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. this new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. it can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.

Eligibility criteria:
inclusion criteria: * adult men or women aged 18 years and older (with no upper age limit). * fracture of the intertrochanteric fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (mri). * operative treatment of fractures within 14 days of presenting to the emergency room. * patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker. * anticipated medical optimalization for operative fixation of the hip. * provision of informed consent by patient or legal guardian. * no other major trauma. exclusion criteria: * patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture). * associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture). * retained hardware around the affected hip. * infection around the hip (i.e., soft tissue or bone). * patients with disorders of bone metabolism except osteoporosis (i.e., paget's disease, renal osteodystrophy, osteomalacia). * moderate or severe cognitively impaired patients (i.e., six item screener with 3 or more errors). * patients with parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. likely problems, in the judgment of the investigators, with maintaining follow-up. we will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.

Keywords: surgery fixation intramedullary nail
breathlessness relieved by employing medical air to be titrated by hospitalized patients to improve inpatient experience

Conditions: Dyspnea

Summary: the breathe-easy is a randomized control trial assessing the efficacy of the novel pneumocool device to alleviate subjective shortness of breath. the pneumocool device is a disposable, bladeless, highly portable device that uses medical-grade air that confers many advantages in a hospital setting.

this will be randomized control trial (rct) for patients admitted to the ohio state university wexner medical center, ross and james cancer hospital. patients will be screened to assess eligibility. the study team will use a 2-group (intervention vs. control) rct design. on meeting inclusion criteria, completed informed consent will be obtained. after informed consent, subjects will be randomized to receive either the pneumocool device or usual therapy. pneumocool setup will be done by the study team. this study will be unblinded, since blinding is not feasible in this device study. conventional therapy will include the patients usual care and any palliation for patients' symptoms ordered by the primary team, including bedside fan if the patient requests. patients will be queried for their symptoms at the time of enrollment, at time 0 (start of first arm of trial) and 8 hours for the primary outcome. patient will be followed throughout their hospital stay until discharge. data will be collected from the electronic medical record. patient and provider satisfaction will be noted.

Eligibility criteria:
inclusion criteria: * dyspnea (borg scale \> 3) * admitted to university hospital, ross or james cancer hospital with expected length of stay \> 24 hours * age 18 years or more exclusion criteria: * delirium (assessed by camicu) or dementia or brain injury precluding ability to consent and or respond to outcome scales * prisoner status * continuous mechanical ventilation * patients with motor disability with inability to maneuver the device